NICE consults on commonly used expensive drugs for leukaemia

NICE consults on commonly used expensive drugs for leukaemia
In new draft guidance, published today, NICE has not been able to recommend dasatinib, high-dose imatinib or nilotinib for the treatment of CML (chronic myeloid leukaemia) that is resistant to standard-dose imatinib.

In response to the draft guidance Andrew Dillon, Chief Executive at NICE, said: "The evidence for the effectiveness of dasatinib, high-dose imatinib and nilotinib is very weak. When we recommend the use of very expensive treatments, we need to be confident that they bring sufficient additional benefit to justify their cost."

Both dasatinib (Sprycel) made by Bristol-Myers Squibb, and nilotinib (Tasigna), made by Novartis cost over £30,000 per patient per year. Novartis has also recently increased the price of imatinib (Glivec) which means the cost per patient is now over £40,000 per year for the high dose of 800mg. Also, CML is a chronic condition, meaning the drugs would be used for a long period of time.

This draft guidance is for the treatment of imatinib-resistant CML only. There are two additional ongoing appraisals: dasatinib and nilotinib for the treatment of CML in people with imatinib intolerance, and dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of CML.

Consultees, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation at Comments received during this consultation will be fully considered by the Committee in June 2011 and following this meeting the next draft guidance will be issued.

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. This draft guidance does not mean that people currently taking dasatinib, high-dose imatinib or nilotinib will stop receiving them. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.


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Notes to Editors
About the guidance
1. The draft guidance will be available on the NICE website from 6 May 2011 at

2. Neither manufacturer has yet submitted a patient access scheme.

3. Chronic myeloid leukaemia is a very rare condition that affects around 560 people in the UK each year. Many are treated with a drug called imatinib. If this treatment does not work, the current options are interferon-alfa, hydroxycarbamide or a bone marrow transplant.

4. In October 2003 NICE published guidance (technology appraisal guidance 70, recommending standard-dose imatinib (400mg) for the first-line treatment of CML. High-dose imatinib was only recommended in the context of further clinical studies.

5. There are currently three ongoing appraisals focusing on the treatment of chronic myeloid leukaemia:

a. Dasatinib, nilotinib and standard-dose imatinib and are being appraised as first-line treatments for CML. Partial review of TA70

b. Dasatinib, high-dose imatinib and nilotinib are being appraised for the treatment of CML that is resistant to imatinib. Partial review of TA70 Draft guidance has been published today.

c. Dasatinib and nilotinib are being appraised for the treatment of CML in people intolerant to imatinib

About NICE
6. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

7. NICE produces guidance in three areas of health:

public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sectorhealth technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHSclinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.8. NICE produces standards for patient care:

quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent servicesQuality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients9. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 05 May 2011